Comparison of the bacterial microbiota in the skin and gut of psoriasis patients before and after sytemic treatment with adalimumab and ustekinumab or cyclosporin - MIPSO

niversitätsklinikum Münster0 sites37 target enrollmentMarch 31, 2015

ConditionsMedDRA - Psoriasis vulgaris (10050576)L40.0 Psoriasis vulgaris

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: MedDRA - Psoriasis vulgaris (10050576)
Sponsor: niversitätsklinikum Münster
Enrollment: 37
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 31, 2015

End Date

September 11, 2017

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversitätsklinikum Münster

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria for all patients:
•1\. Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI \= 10\).
•2\. \> 18 years (male and female).
•3\. Treatment according to the guidelines and standard therapies for
•psoriasis with adalimumab, ustekinumab or cyclosporine.
•Additional inclusion criteria for patients who will receive adalimumab or ustekinumab:
•1\.Patients with moderate or severe chronic plaque psoriasis who did not respond to other systemic therapy such as cyclosporine, methotrexate, or PUVA or patients with contraindications or intolerance to such a therapy.
•Additional inclusion criteria for patients who will receive cyclosporine:
•1\.Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI \= 10\) who are not adequately treatable with conventional systemic therapy.

Exclusion Criteria

•Exclusion criteria for all patients:
•1\.Patients treated with systemic immunosuppressives, adalimumab, etanercept, ustekinumab or infliximab within a period of 5 half\-life periods of the respective drug before taking the initial skin swabs /biopsies.
•2\.Simultaneous therapy with systemic immunosuppressives.
•3\.Patients treated with antibiotics within at least 4 weeks before taking the initial skin swabs/biopsies or patients treated with antibiotics in the course of the trial with the exception of tuberculosis prophylaxis with Isoniazid.
•4\.Psoriasis patients who currently receive phototherapy or have received phototherapy within a period of 2 weeks before taking the initial skin swabs/biopsies 5\.Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in skin areas chosen for the skin swabs/biopsies. Topical treatment with calcineurin inhibitors or vitamin D3 analogues may be continued in lesional skin areas that are not intended for swabs/biopsies. In skin areas chosen for the swabs/biopsies topical therapy is not allowed within 7 days before sampling.
•6\.Patients with relevant active infections (e.g. active tuberculosis or other severe infections such as sepsis and opportunistic infections). 7\.HbsAG\-positive patients. HCV\-PCR\-positive patients.
•8\.HIV\-positive patients.
•9\.Current malignancies or history of malignancies.
•10\.Immunodeficient patients.
•11\.Patients who currently receive chemotherapy or radiotherapy or received chemotherapy or radiotherapy within the last 12 months prior to sampling of the initial skin swabs/biopsies.